# K982271: Wako Direct LDL-C

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Sep 22, 1998 after 85 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Equal LDL Direct Liquid Select Cholesterol reagent: named in the summary without a submission number

## Most influential descendants
- K993741: EZ LDL Cholesterol Test System (2000), 0 descendants of its own

## Indications for use
A LOL- C‘AD\CQ!(VD\ ksF S\/S‘tm ¢ a dt}il’k wlendead o nealuve LDL'C\/\OLLAW " p\a/:w:x, wmd %vwm-\fl,(,\/\ousM rvu.a/m)w\,\,u,mH ot Wil th %9«4 c‘.l‘CUVLOLfl\c) O-I/Ld '!’WQWVL{" Q(: C\: covdev 4 imvopvn‘V\fi LRLLES cuo\uskwp ‘e blood ovd Lpid and Lipoprok v mefaboliowa disovdevs.

Source page: https://510kreport.com/device/K982271
Methodology: https://510kreport.com/methodology